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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  05/08/2008
 
Trade Name:  Desmopressin acetate Tablets, 0.1 mg and 0.2 mg
 
Generic Name or Proper Name (*):  desmopressin acetate
 
Indications Studied:  Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE)
 
Label Changes Summary:  * Efficacy in RCCT was evaluated in a single trial with children 3 to 18 years old * Three studies evaluated efficacy in children 5 to 17 years old with PNE; an additional study evaluated efficacy in adolescents 12 to 17 years old * Fluid intake should be adjusted downward in children to decrease the potential occurrence of water intoxication and hyponatremia * Dosing information provided for children 3 to 18 years old for RCCT * Dosing information provided for pediatric patients 6 years of age and older with PNE * Tablet dosage and administration information provided for children with central diabetes insipidus * Pharmacokinetics and pharmacodynamics were evaluated in children * New indications and dosing regimen
 
PREA(P):  P
 
Sponsor:  Ferring
 
NNPS:  FALSE
 
Therapeutic Category:  Urology
 
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